This invention generally relates to a process and product for separately storing a sterilized powdered component and a sterilized liquid component within a single, aseptic unit container. More particularly, this invention relates to a process and product wherein two separate chambers are provided in a unit container or bag, which separate chambers are interconnected by a sterilized frangible connector that provides a closed connection between the chambers. Such closed connection is manually opened when it is desired to mix the liquid and the powder together in order to form a solution of the powder within the liquid, which solution is sterile and dispensible from the container in liquid form.
With regard to the dispensing of medicaments, it is often the case that the pharmaceutically active component is provided in powdered form and it is desired to administer the pharmaceutical within a carrier liquid, for example, in order to dispense the pharmaceutical by an intravenous procedure. Exemplary carrier liquids include saline solution, dextrose solution, and sterilized water. Often, such pharmaceutical powders are subject to deterioration if stored for long periods of time within the carrier liquid, as a result of which it is desirable to maintain the powdered component separate from the liquid component up until a time immediately prior to actual use by the physican or medical support staff. In such instances, it is typically desirable to avoid any possibility of contamination of the liquid-powder mixture, either before, during or after the liquid or powder components are mixed together. Besides the concern for maintaining clean conditions, it is also desirable at times to avoid exposure of the physician, medical support staff or pharmacist to certain unusually active drugs such as those used in chemotherapy treatment.
Powdered pharmaceuticals usually are sterilized by the drug manufacturer within a sterilized vial, typically of glass construction. Such vials have caps that are readily punctured in order to permit removal of the sterile powdered contents thereof into a carrier liquid or the like. Although these vials are usually provided in as clean a state as possible, the external features thereof do provide potential sources for mold or bacterial growth on the outside of the vial, such potential sources including the stopper and its overcap for sealing the mouth of the vial, the informational label that is affixed to the outside of the vial, and the adhesive utilized to affix the label. Nevertheless, because such vials have wide acceptance and enjoy a certain amount of uniformity throughout the medical industry, it is unlikely that the use of these vials in this manner will be phased out in the near future.
Mold or bacterial growth on the surface of non-porous containers or bags is sometimes observed when such bags are stored for substantial time periods within overpouches that serve as a barrier to the transmission of gas, light and water vapor to the bag within the overpouch. Often, because such barriers are not absolute or because some residual moisture remained between the bag and the overpouch at the time that the overpouch was sealed over the bag, mold growth can occur, especially since moisture and temperature conditions that are highly conducive to mold or bacterial growth are usually present between the bag and the pouch, or at other locations such as at an interface between a glass vial and support means therefor.
Accordingly, there is a need for a system that maintains sterile conditions within both a powdered pharmaceutical and its intended carrier liquid, while at the same time substantially eliminating any possibility of mold or bacterial growth between adjoining surfaces of the packaging for such sterilized medicaments. Also needed is a unitary device for separately packaging the carrier liquid and the powdered medicament that requires no direct contact with the rigid vial containing the powdered medicament, or the contents thereof, by the physician, pharmacist, or medical staff member. These needs are satisfied by the present invention through the use of several steps whereby a liquid component within a flexible container or bag is first sterilized under relatively harsh conditions, a sterilized powder-containing vial is maintained in an aseptic condition and is inserted into an enclosed chamber of the flexible bag and sealed therewithin.
It is accordingly a general object of this invention to provide a composite device for separate storage of a powder and a liquid.
Another object of this invention is to provide means for utilizing vials of powdered adhesive within a system that avoids potential sources of contamination originating from the vials.
Another object of the present invention is a product and process for its production whereby a sterile liquid and a sterile powder are separately packaged within a single unit in a manner that provides for mixing of the liquid and powder under sterile conditions.
Another object of this invention is an improved process for packaging a sterilized liquid carrier and a powdered pharmaceutical in a manner that minimizes any possible introduction of sources of bacteria, mold or the like either within or on the surface of the liquid container or the container for the powdered component.
Another object of the present invention is an improved product and process for its production wherein the entire outer surface of a powder-containing vial is rendered aseptic and packaged so as to be maintained in its aseptic condition.
Another object of the present invention is an improved process and product whereby a rigid vial is encapsulated in an aseptic state.